This is a single-center, randomized-controlled trial to investigate the effectiveness of an ERAS protocol compared to usual care in patients with bladder cancer undergoing ambulatory TURBT. The ERAS protocol is comprised of pre, intra and postoperative components designed to optimize each phase of perioperative care.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
The ERAS protocol for ambulatory TURBT has been designed based on patient and provider input, a needs assessment of 150 patients in the hours after TURBT, a review of the literature, and experience with other ambulatory ERAS protocols already implemented at Johns Hopkins Hospital. The ERAS protocol for ambulatory TURBT aims to optimize care delivered in the pre, intra and postoperative settings.
Patients in the usual care arm of the EMBRACE trial will experience the present-day care pathway of ambulatory TURBT at Johns Hopkins Hospital.
Johns Hopkins Hospital
Baltimore, Maryland, United States
Change in quality of recovery as assessed by Quality-of-Recovery 15 Scores (QoR-15)
The QoR-15 score is a validated 15-item questionnaire that assesses quality of recovery in five dimensions: pain, physical comfort, functional autonomy, emotions, and psychological support. Each item is scored 0 to 10 with higher scores representing superior quality of recovery. The QoR-15 score is patient-reported outcome measure and has been extensively used to evaluate ERAS for both inpatient and ambulatory surgeries. It is a shorter and more patient-friendly version of the QoR-40 with equivalent psychometric properties.
Time frame: Measured at enrollment through study completion, an average of 7 days.
Change in lower urinary tract symptoms as assessed by the Urinary Tract Infection-Symptom and Impairment Questionnaire (UTI-SIQ-8)
The UTI-SIQ-8 is a validated questionnaire of voiding symptom severity and bother, with higher scores representing worse symptoms (8-40).
Time frame: Measured at enrollment through study completion, an average of 7 days.
Change in quality of life for bladder cancer patients as assessed by the Bladder Utility Symptom Scale (BUSS)
Bladder Utility Symptom Scale - a validated 10-question instrument designed specifically for patients with bladder cancer, will be used to measure health-related quality of life (0-100), with higher scores representing higher quality of life.
Time frame: Measured at enrollment through study completion, an average of 7 days.
Change in Pain as assessed by Visual Analogue Scale
Dysuria, Suprapubic/Bladder, Urethral, Penis or Vulvar Pain Rated from 0 (No pain) to 10 (Unbearable pain)
Time frame: Measured at enrollment through study completion, an average of 7 days.
Change in patient satisfaction as assessed by patient self-report
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Self-reported on a scale of 1 (lowest satisfaction) to 10 (highest satisfaction).
Time frame: Measured at enrollment through study completion, an average of 7 days.
Change in degree of hematuria as assessed by patient self-report
None, Pink, Red, Red with Clots as self-reported by patients
Time frame: Measured at enrollment through study completion, an average of 7 days.
Change in incontinence
Change in incontinence will be assessed by the average number of pads used per day
Time frame: Average daily pad use measured at enrollment Measured at enrollment through study completion, an average of 7 days.
Change in opioid consumption
Change in opioid consumption (Morphine milligram equivalents) obtained from medical record
Time frame: Measured at enrollment through study completion, an average of 7 days.
Healthcare utilization
Number of unplanned post-procedural ambulatory visits, emergency department visits, phone calls, and electronic messages assessed individually.
Time frame: Measured at enrollment through study completion, an average of 30 days.
Complications as assessed by Clavien-Dindo complications
Surgical complications as classified by Clavien-Dindo category.
Time frame: Measured at enrollment through study completion, an average of 30 days.